LA JOLLA, Calif.--(BUSINESS WIRE)--Trio Health, a leading provider of retrospective observational data on real world patients, today announced results from several of its research programs that reveal critical, and often counterintuitive, insights regarding the delivery and utilization of healthcare across the United States. The Company is highlighting these data in response to the U.S. Food and Drug Administration’s (FDA) recently announced framework on the collection and utilization of real world evidence (RWE) to improve its regulatory decisions, and ultimately enhance treatment by providing insights to inform prescribing decisions.
“We’re pleased that the FDA has taken a proactive and supportive position on RWE, and look forward to utilizing our technology platform to provide insightful data which shows how medications perform in the hands of doctors and patients, and how payer coverage can impact care,” said Brent Clough, CEO of Trio Health.
As an organization dedicated to improving patient care through the collection and management of real world data, Trio publishes its findings at major medical conferences through independent Scientific Steering Committees comprised of thought leaders with specific expertise, to provide credible and unbiased insight for each disease.
“The benefit of Trio’s unique methodology lies in understanding the patient’s touchpoints with each healthcare stakeholder throughout the treatment journey,” continued Clough. “With our platform, it’s now possible to understand, in real time, the real world experience of the patient. From the physician’s prescription, to the pharmacy, then the payer, and ultimately to the patient, we provide unparalleled insights into the delivery and utilization of healthcare.”
Revealing real world insights about treating prevalent diseases
While it ultimately provides critical intelligence, obtaining useable RWE requires the guidance of key opinion leaders to focus the research and appropriate technology to optimize raw data and create insights. Trio delivers transparent, unbiased insights about study methodologies, statistical relevance, and feasibility of the underlying data. Highlights of findings from some of its recently published studies include:
- Concurrent medications represent a challenge for patients with certain diseases, as interactions between multiple therapies may produce adverse events or impact the effectiveness of a treatment. For people with Hepatitis C (HCV), one such concern was originally reported for patients taking proton pump inhibitors (PPI) and prescribed the anti-HCV therapy, Harvoni, which becomes active in the stomach’s acidic environment. Since PPIs reduce stomach acidity, the concern was that Harvoni would be less effective. Trio’s real world evaluation found that PPI usage was not associated with reduced effectiveness of the treatment, effectively reassuring physicians about the use of Harvoni in patients requiring PPIs, and enabling doctors to have confidence in their prescribing decision.i
- Patients with hemophilia A, a rare disorder that prevents blood clotting, often require infusions of blood Factor VIII (FVIII) to prevent and control bleeding. Prophylactic therapy with FVIII is effective in reducing breakthrough bleeding, but may require 3-4 injections per week, which is a burden for both the patient and physician. Adynovate, a newer FVIII has a longer half-life than other short half-life factors. Trio’s real-world evaluation found that after switching to Adynovate, patients decreased drug consumption and reduced administrations by 21%, from 2.8 administrations per week to 2.2. Additionally, use of prophylactic Adynovate reduced breakthrough bleeding by 73%, from an annualized bleed rate of 5.9 to 1.6.ii
- For HIV patients, treatment regimens consisting of antiretrovirals in single-tablet formulations can be more costly than regimens comprised of multiple tablets. Higher costs of single-tablet treatment may be offset by enhanced efficacy resulting from improved adherence. To assess single- and multiple-tablet regimen efficacy, Trio evaluated the experiences of patients with longer duration of therapy on single- versus multiple-tablet regimens. Results showed that adherence was improved with single-tablet regiments, with 88% of patients having 80% or higher compliance, compared to 71% of patients taking multiple-tablet regimens.iii
“Trio Health is committed to making the use of RWE efficient, so that industry can effectively use these insights to improve patient outcomes,” summarized Clough. “We believe that the already widespread adoption of RWE will continue to expand, and look forward to seeing the FDA continue to encourage use of these data to inform treatment decisions.”
About Trio Health
Trio Health’s mission is to improve the quality of care in patient outcomes through coordinating the efforts of all patient care stakeholders. Their first-of-its-kind Innervation platform tracks patients throughout the course of their treatment, giving pharmaceutical/biotechnology companies, specialty pharmacies and physicians access to information and opportunities that simply don’t exist anywhere else. Learn more at www.triohealth.com.
i Tapper, EB et al. Evaluation of proton pump inhibitor use
on treatment outcomes with ledipasvir and sofosbuvir in a real-world
cohort study. Hepatology. 2016 Dec;64(6):1893-1899.
ii Watt, M et al. A Retrospective, Observational Study of BAX 855 in Clinical Practice in the United States (AMCP 2018)
iii Mills, A et al. Adherence and Persistency with Modern Single vs Multi-Tablet Antiretroviral (ARV) Regimens in 1st treatment of HIV in Clinical Practice. IDWeek 2018 THU-550.